Safety and Efficacy of Doses of Ingenol Mebutate Once Daily for Two or Three Consecutive Days in Subjects With Actinic Keratosis

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To identify the Maximum Tolerated Dose levels of ingenol mebutate gel after once daily treatment for 2 or 3 consecutive days and to evaluate efficacy of ingenol mebutate gel in different doses after once daily treatment for 2 or 3 consecutive days compared to vehicle gel

Safety and Efficacy of Escalating Doses of Ingenol Mebutate Once Daily for Two or Three Consecutive Days When Used on Full Face, Full Balding Scalp or Approximately 250 cm2 on the Chest in Subjects With Actinic Keratosis

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Subjects must be competent to understand the nature of the trial and provide informed consent

Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the face Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on either the face, the balding scalp (the balding part of the scalp should be at least 25 cm2) or a contiguous area of approximately 250 cm2 on the chest

Subject at least 18 years of age

Female subjects must be of either:

Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,

Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to trial treatment, to rule out pregnancy

Female subjects of childbearing potential1 must be willing to use effective contraception at trial entry and until completion

Exclusion Criteria:

Location of the treatment area (full face, full balding scalp or chest)

recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions

History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g., eczema, unstable psoriasis, xeroderma pigmentosum)

Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the treatment areas.

Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety and efficacy during the course of the trial, as determined by the investigator's clinical judgment

Any abnormal laboratory tests that are medically significant and would impact the safety of the subjects or the interpretation of the trial results, as determined by the investigator's judgment

Anticipated need for hospitalisation or out-patient surgery during the first 15 days after the first trial medication application. Note that cosmetic/therapeutic procedures are not excluded if they fall outside of the criteria detailed in Prohibited Therapies or Medications

Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel

Presence of acute sunburn within the treatment areas

Current enrolment or participation in an investigational clinical trial within 30 days of entry into this trial.

Subjects previously assigned to treatment in Part 1 or rand

Female subjects who are breastfeeding.

In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state)